Multi-functional second instrument for cataract removal

ABSTRACT

Apparatus for the removal of lens tissue includes a first instrument for inserting into a lens capsule and removing a cataract therein, the first instrument including a lumen for aspiration of cataract tissue and irrigation fluid from the lens capsule and manipulate the cataract until cataract is removed. The second instrument includes an irrigation port for introducing the irrigation fluid into the lens capsule.

The present application is a continuation-in-part of U.S. patentapplication Ser. No. ______ filed ______.

The present invention generally relates to surgical instruments, andmore particularly, relates to apparatus which provides for improvedirrigation and reduced risk of corneal or sclera tissue damage duringcataract removal.

Cataracts cause the lens of an eye to become clouded, and a commonpractice to alleviate this condition is by surgically removing thecataractic lens and replacing it with an artificial intraocular lens.

Early lens removal was effected through manual extraction which requireda wound of about 12 mm in length. This large opening can result incorneal or sclera tissue damage.

Phacoemulsification, on the other hand, enables the removal of acataractic lens through a much smaller incision, for example, betweenabout 2.5 to about 4 mm. In this procedure, a needle is inserted throughthe incision into a lens capsule and the needle is vibrated tomechanically emulsify the lens. It is often desirable to utilize asecond tool in order to manipulate the lens toward and around thephacoemulsification needle in order to more effectively emulsify thelens. Once fragmented or emulsified, the lens material is aspiratedthrough a lumen through the phacoemulsification needle.

Heretofore, while emulsifying the lens and aspirating lens fragments, asimultaneous flow of irrigation fluid into the lens capsule has beenprovided around the needle through an annulus established by a sleeveconcentrically disposed over the needle. This flow of liquid into theeye is necessary to prevent collapse of the interior chamber of the eyeduring aspiration. In addition, the irrigation fluid cools the needle inorder to prevent any thermal damage of the corneal or sclera tissue.While the sleeve surrounding a phacoemulsification needle provides theimportant function of establishing an annulus for introducing irrigationfluid into the lens capsule it also enlarges the overall diameter of thesleeve needle for which an incision must be made.

In addition, when irrigation fluid is introduced proximate theemulsifying needle tip, the immediate area in front of the needle isroiled. This occurs because of the counter-current flow of fluid beingaspirated by the needle itself and the irrigation fluid being introducedover the surface of the needle. Needle vibration causes a cloud ofdebris which is roiled by the incoming infusion fluid which lessens thephysicians visual acuity of the end of the needle which can slow theprocedure. This roiling also pushes nuclear fragments away from theneedle rendering the procedure less efficient.

The present invention overcomes the drawbacks of a sleevedphacoemulsification needle.

SUMMARY OF THE INVENTION

Apparatus in accordance with the present invention includes a firstinstrument for inserting into a lens capsule and removing a cataracttherein, the needle including a lumen therethrough for aspiration oflens tissue and irrigation fluid from said lens capsule through aprimary aspiration port defined by an end of said lumen and a secondinstrument for inserting into the lens capsule and manipulating thecataract as the cataract is being removed, said second instrument havingan irrigation port for introducing the irrigation fluid into said lenscapsule.

More specifically, the second instrument may include a tip, such as ahook or blade, attached to a shaft for manipulating the cataract and theshaft includes a shaft lumen for delivery the irrigation fluid to theirrigation port. Alternatively, the second instrument may include aconduit attached to the shaft, for delivering the irrigation fluid tothe irrigation port. Further, a plurality of irrigation ports may beprovided, each in fluid communication with the shaft lumen or conduit.

More specifically, the first instrument may include a sonic orultrasonic device needle for emulsifying the lens tissue. In thisinstance, the needle includes a lumen for aspiration of emulsifying lenstissue and aspiration flow from the lens capsule.

BRIEF DESCRIPTION OF THE DRAWINGS

The advantages and features of the present invention will be betterunderstood by the following description when considered in conjunctionwith the accompanying drawings in which:

FIG. 1 is a diagram of apparatus in accordance with the presentinvention generally showing a first needle for introducing an irrigationfluid into a lens capsule through a handpiece from an operating consolealong with a second vibrated needle for inserting into the lens capsuleand operated by a phacoemulsification handpiece connected to anaspiration line and controlled by the console through an ultrasonicpower line;

FIG. 2 is a view of the vibrated needle shown in FIG. 1 showing aprimary aspiration port along with two secondary aspiration ports formedin the needle in a spaced apart distance from the primary aspirationport;

FIG. 3 is a view of the needle tip shown in FIG. 2 illustratingnon-turbulent aspiration of lens tissue and irrigation fluid;

FIG. 4 is a similar view of a prior art sleeved needle top illustratingturbulence or roiling of fluid in front of the needle tip caused bycountercurrent fluid flow with results in a cloud of emulsified lenstissue and repulsion of the same;

FIG. 5 is a diagram of alternative apparatus in accordance with thepresent invention generally showing a first instrument including avibrated needle for inserting into a lens capsule and operation by ahandpiece connected to an aspiration line and controlled by a consolethrough a power line along with a second instrument for inserting intothe lens capsule for manipulating a cataract during removal thereof andfor providing irrigation fluid to the lens capsule;

FIG. 6 is an enlarged representation of a second instrument tipillustrating introduction of irrigation fluid through irrigation portsfrom a lumen in a shaft supporting a tool tip;

FIG. 7 is similar to FIG. 6 illustrating the introduction of irrigationfluid through irrigation ports from a conduit adhered to a shaftsupporting a tool tip; and

FIG. 8 is similar to FIG. 6 illustrating a different tool tip which maybe fixed to a separate shaft or used as a replaceable tip.

DETAILED DESCRIPTION

With reference to FIG. 1, there is shown apparatus 10 for the removal oflens tissue 12 which includes a first needle 14 for introducing anirrigation fluid indicated by the arrow 18 into a lens capsule 20.

Manipulation of the needle 14 within the lens capsule 20 is effectedthrough a handpiece 24 which communicates to a control console 26through an irrigation line 28. The control console 26 may be of anysuitable type as for example, one manufactured by Allergan, Inc., underthe trade name Sovereign.

Also shown in FIG. 1, as well as in FIG. 2, is a second needle 32 whichis ultrasonically vibrated by a handpiece 34. Any suitable handpiece maybe utilized such as for example, one sold by Allergan, Inc., under thetrade name Sovereign. The handpiece 34 is interconnected to the console26 and control thereby through an aspiration line 38 and a power line 40for controlling ultrasonic power delivered to the needle 32 by thehandpiece 34.

The second needle 32 fragments or emulsifies the cataractic lens 12which is then aspirated along with irrigation fluid through a lumen 42in the needle 32 as indicated by the arrow 44. Manipulation of theirrigating needle 14 is effective in enabling more efficient removal ofthe cataractic lens 12 as the fluid is now a manipulation tool, movingfragments of lens 12 to the needle 32.

Because the needle 32 does not include a conventional sleeve (not shownin FIGS. 1 and 2) a smaller incision or wound 50 is required. The woundsize may be as small as 0.8 mm which is to be compared with conventionalsleeved needles (not shown) which would require a slit or wound opening,of about 2.5 to 3 mm (or larger).

As more clearly shown in FIG. 2, the needle 32 includes a primaryaspiration port 52 defined by the lumen 42 and one or more secondaryaspiration ports 54, 56 disposed along a length 60 of the needle 32between the primary aspiration port 52 and a hub 62 for attachment ofthe needle 32 to the handpiece 34.

The secondary aspiration ports 54, 56 may be spaced apart axially fromthe primary aspiration port and one another as shown in FIG. 2 or,alternatively, as shown in FIG. 1, aspiration ports 64, 66 may bedisposed along the needle 32 in a spaced apart radial relationship withone another resulting in aspiration of fluid from the lens capsule 20 inopposing direction as indicated by the arrows 70, 72.

The secondary aspiration ports 54, 56, 64, 66 also provide an importantfunction in maintaining the fluid flow through the needle should theprimary aspiration port 52 become occluded. This insures cooling of theneedle 32 to prevent overheating thereof. Preferably, the secondaryaspiration ports 54, 56, 64, 66 are disposed within 6 mm of the primaryaspiration port to insure that their aspirating functionality isperformed within the lens capsule 20. In order to insure that themajority of aspiration occurs through the primary aspiration port, it ispreferred that the total cross-sectional area of the secondaryaspiration ports 54, 56, 64, 66 be no more than 10% of thecross-sectional area of the primary aspiration port 52.

The advantages of the unsleeved needle 32 are more clearly understoodwith reference to FIGS. 3 and 4. FIG. 3 illustrates smooth laminar flowof aspiration fluid as shown by the arrows 78 into the primaryaspiration port 52 and secondary aspiration ports 64, 66.

This is to be contrasted with a conventional phacoemulsification needletip 80 which is surrounded by a sleeve 82 for the introduction ofirrigation fluid proximate to an aspiration port 84 as indicated by thearrows 86. The sleeve 82 also has side holes 88 for irrigation outflow.

As illustrated, aspiration of fluid as indicated by the arrows 90, 92may be partially diverted from the port 84 before entering which causesa roiling of the fluid indicated by the arrows 96, 98. This roiling offluid causes a “milky cloud” to appear proximate the needle tip 80 andpushes lens fragments away which interferes with the physician acuity ofthe needle tip 80 which interferes with efficient phacoemulsification oflens tissue, not shown in FIG. 4.

With reference to FIG. 5, there is shown in an alternative embodiment100 in accordance with the present invention, in reference, charactersrefer to a similar or substantially identical elements hereinabovediscussed in connection with the embodiment 10 shown in FIG. 1.

Embodiment 100 includes a first instrument 102 which includes a vibratedneedle 104 for inserting into a lens capsule 106 for removing a cataract108 therein. The needle 104 includes a lumen 112 therethrough foraspiration of cataract tissue from the lens through a primary aspirationport 114 defined by an end 116 of the needle 104, this aspiration isindicated by the arrow 118. Preferably, second aspiration ports 120, 122are provided in the needle 112 for aspirating cataractic tissue, as wellas irrigation fluid, from the lens capsule 106 as indicated by thearrows 126, 128.

A second instrument 130, which includes a shaft 132 and tool tip 134, isinserted into the lens capsule 106 for manipulating the cataract to 108as the cataract 108 as being emulsified by the needle 104.

The second instrument 130 includes one or more irrigation ports 136,138, 140 for introducing irrigation fluid into the eye capsule 106 asindicated by the arrows 140.

An enlarged view of the tool tip 34 and shaft 132 are shown in FIG. 6.Irrigation fluid is provided to the ports 138, 140 shown in FIG. 6through a lumen 146 within the shaft 132. Alternatively, as shown inFIG. 7, the tool tip 34 may be supported by a solid shaft 148 and aseparate conduit 150 may be utilized to provide irrigation fluid toirrigation ports 152, 154.

The tool tip 134 may be of any suitable type, such as for example, ahook or a blade, for manipulation of the cataractic tissue 108 and maybe fixed to a shaft 148 as shown in FIG. 7 or removably coupled to ashaft 132 by a conventional coupling mechanism 160. When a coupler 160is utilized, alternative tool tips 162, as shown in FIG. 8, may beattached to the shaft 132 by the user.

The irrigation ports 138, 140, 152, 154 are preferably spaced apartaxially on the shaft 132, 148 respectively or, as illustrated in FIG. 5,there may be also space radially about the shaft. The size of the ports138, 140, 152, 154 may be 0.6 to 1.5 mm in order to introduce irrigationfluid at the rate of 20-60 cc/min. The irrigation port 138, 140, 152,154 size and location is dependant upon surgeon technique and incisionlocation.

Although there has been hereinabove described apparatus for the removalof lens tissue in accordance with the present invention for the purposesof illustrating in which the manner in which the invention may be usedto an advantage, it will be appreciated that the invention is notlimited thereto. Accordingly, any and all modifications, variations, orequivalent arrangements which may occur to those skilled in the artshould be considered to be within the scope of the invention as definedin the appended claims.

1-21. cancelled.
 22. Apparatus for the removal of lens tissue, saidapparatus comprising: a first instrument having a shaft insertable intoa lens capsule and a manipulating tool tip, said first instrument havingan irrigation port introducing irrigation fluid into said lens capsule;and a second instrument, including an unsleeved vibrated cataractremoving needle insertable into the lens capsule, the second instrumentincluding a lumen therethrough aspirating emulsified cataract tissue andirrigation fluid from said lens capsule, said unsleeved vibrated needlehaving a diameter enabling insertion of said unsleeved vibrated needlethrough a wound opening of less than about 2 mm.
 23. The apparatusaccording to claim 22 wherein said shaft includes an irrigation fluiddelivery shaft lumen therethrough.
 24. The apparatus according to claim22 wherein said first instrument comprises a conduit, attached to saidshaft, delivering the irrigation fluid to said irrigation port.
 25. Theapparatus according to claim 22 wherein said first instrument comprisesa plurality of irrigation delivery ports.
 26. Apparatus for thephacoemulsification of lens tissue, said apparatus comprising: a firstinstrument having a shaft insertable into a lens capsule and amanipulating tool tip, said first instrument having an irrigation portintroducing irrigation fluid into said lens capsule; a secondinstrument, including an ultrasonically vibrated unsleeved needleinsertable into the lens capsule and emulsifying the cataract therein,the needle including lumen therethrough aspirating emulsified cataracttissue and irrigation fluid from said lens capsule through a primaryaspiration port defined by an end of said lumen, the unsleeved needlehaving a diameter enabling insertion of the unsleeved needle through awound opening of less than about 2 mm; a plurality of manipulating tooltips; and a coupling medium removably coupling each of said plurality oftool tips to said shaft.
 27. The apparatus according to claim 26 whereinsaid shaft includes an irrigation fluid delivery shaft lumen.
 28. Theapparatus according to claim 26 wherein said first instrument comprisesa conduit, attached to said shaft, delivering the irrigation fluid tosaid irrigation port.
 29. The apparatus according to claim 26 whereinsaid first instrument comprises a plurality of irrigation deliveryports.
 30. The apparatus according to claim 26 wherein each tool tip ismounted transverse to said shaft.
 31. The apparatus according to claim30 wherein at least one of said plurality of tool tips comprises a solidblade.
 32. The apparatus according to claim 30 wherein at least one ofsaid plurality of tool tips comprises a solid hook.
 33. The apparatusaccording to claim 30 wherein said shaft includes a shaft lumentherethrough for delivering the irrigation fluid to said irrigationport.